Non-Small Cell Lung CancerPhase 2NCT00308750
First Line Chemotherapy Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing enzastaurin, pemetrexed and docetaxel in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 4 sites in United States.
Trial summary
The purposes of this study are to determine: The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or docetaxel with carboplatin and any side effects that might be associated with the combination of these drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- enzastaurin, pemetrexed and docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2006to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You must have been diagnosed with NSCLC.
- You must be able to visit the doctor's office weekly during the active treatment period and as needed during the study follow-up period.
- You must be willing and able to swallow capsules.
- Your entry labs and medical tests must meet study requirements.
- You must be willing to have blood samples drawn and tissue samples obtained for gene and protein testing.
Who cannot join
- You have received radiation within 2 weeks of study enrollment.
- You have previously received any anti-cancer drug therapy for NSCLC.
- You have an active infection or other serious condition.
- You take aspirin or aspirin-like medication regularly and are not able to stop taking them for a few days during each cycle of chemotherapy.
- You have recently lost a significant amount of weight.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Burlington, North Carolina, 27215
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chapel Hill, North Carolina, 27599
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Columbia, South Carolina, 29210
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Houston, Texas, 77060
About this study
Official title: A Randomized, Open-label Phase II Study of Pemetrexed (Alimta) Plus Carboplatin With or Without Enzastaurin Hydrochloride, or Docetaxel Plus Carboplatin as First Line Treatment in Patients With Advanced Stage Non-small Cell Lung Cancer (NSCLC)
The purposes of this study are to determine:
The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or docetaxel with carboplatin and any side effects that might be associated with the combination of these drugs.
Read more
Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can help participants with non-small cell lung cancer (NSCLC) live longer, compared with the combination of docetaxel and carboplatin.
Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can make your tumor smaller or disappear, and for how long, compared with the combination of docetaxel and carboplatin.
The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or docetaxel with carboplatin have on your disease related symptoms.
The relation of smoking history and hormone replacement therapy (for women only) may have to your lung cancer treatment results.
The effects of certain genes and proteins in samples of your blood and tumor tissue in order to learn more about NSCLC and how enzastaurin works in the body.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- enzastaurin, pemetrexed, docetaxel, carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzastaurinDrug
Also called LY317615
1125-1200 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression
pemetrexedDrug
Also called LY231514, Alimta
500 milligrams per square meter (mg/m^2), intravenous (IV), once every (q) 21 days, six 21 day cycles or progressive disease
docetaxelDrug
75 mg/m^2, IV, q 21 days, six 21 day cycles or progressive disease
carboplatinDrug
Area under the curve (AUC) 6, IV, q 21 days, six 21 day cycles or progressive disease
| Study group | Role | What they receive |
|---|---|---|
| Enzastaurin/Pemetrexed/Carboplatin | Experimental | Not described Receives: Drug: enzastaurin; Drug: pemetrexed; Drug: carboplatin |
| Pemetrexed/Carboplatin | Experimental | Not described Receives: Drug: pemetrexed; Drug: carboplatin |
| Docetaxel/Carboplatin | Active comparator | Not described Receives: Drug: docetaxel; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression
Time to disease progression was defined as the time from randomization to the first date of documented disease progression or death if the participant dies due to disease progression. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions. For participants who have not had documented disease progression, time to disease progression was censored at the date of death or date of last visit. For participants who received other anti-tumor therapy prior to disease progression, time to disease progression was censored at the first available date of other anti-tumor therapy.
Measured: Baseline to measured PD up to 22.3 months
Secondary outcomes (9)
Tumor Biomarkers Associated With Clinical Outcomes
As specified in the protocol, tumor biomarker samples were collected from participants on the pemetrexed arms only but were not intended to be analyzed at the individual study level.
Measured: Baseline, Cycle 1, Cycle 2 (21-day cycle each), and 30-day post study treatment follow-up
Assessment of Smoking History (All Participants) and Hormone Replacement Therapy (Female Participants Only) Associated With Clinical Outcomes
Data for smoking history and hormone replacement therapy were collected but were not intended to be analyzed at the individual study level.
Measured: Baseline
Number of Participants With Adverse Events (AEs) or Deaths
Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality, or deaths during the study including 30 days after treatment discontinuation. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report.
Measured: Baseline through study completion up to 6 cycles (21-day cycle each) and 30-day safety follow-up
Change From Baseline in Total Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale
The FACT-L version 4 scale is used to assess health-related quality of life (HRQoL) in participants with lung cancer. The FACT-L has 5 subscales: Physical Well-Being (PWB), Social and Family Well-Being (SFWB) and Functional Well-Being (FWB) subscales which include 7 items each, Emotional Well-Being (EWB) subscale which includes 6 items, and a Lung-Cancer Specific (LCS) subscale which include 7 items. Total FACT-L is the sum of all 5 subscales. Each item is scored from 0 to 4 giving a total overall score from 0 equal to "worst quality of life" to 136 equal to "best quality of life". The Least Square (LS) mean was calculated using an analysis of covariance (ANCOVA) model adjusted for change scores and baseline scores.
Measured: Baseline, Cycle 1 (Week 3), Cycle 2 (Week 6), Cycle 3 (Week 9), Cycle 4 (Week 12), Cycle 5 (Week 15) and Cycle 6 (Week 18) [21-day cycle each]
Change From Baseline in Total Functional Assessment of Cancer Therapy -Taxane (FACT-Taxane) Scale
The FACT-Taxane version 4 scale is used to assess HRQoL in participants receiving taxane chemotherapy. The FACT-taxane has 5 subscales: PWB, SFWB, and FWB subscales which include 7 items each, EWB subscale which includes 6 items, and a taxane subscale which include 16 items and has two domains (neurotoxicity and taxane). Total FACT-Taxane is the sum of all the 5 subscales. Each item is scored from 0 to 4 giving a total overall score from 0 "worst quality of life" to 172 "best quality of life". The LS mean was calculated using an ANCOVA model adjusted for change scores and baseline scores.
Measured: Baseline, Cycle 1 (Week 3), Cycle 2 (Week 6), Cycle 3 (Week 9), Cycle 4 (Week 12), Cycle 5 (Week 15) and Cycle 6 (Week 18) [21-day cycle each]
Overall Survival (OS)
OS was the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.
Measured: Baseline to date of death from any cause up to 35 months
Number of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response]
Response was defined using RECIST, version 1.0 criteria. Participants with a best response of CR or PR were considered to have had a tumor response. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.
Measured: Baseline to measured PD up to 22.3 months
Duration of CR or PR (Duration of Response)
The duration of a CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of progression or death due to any cause. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.
Measured: Date of first response to the date of progression or death due to any cause up to 22.3 months
Time-to-Treatment Failure (TTF)
TTF was defined as the time from randomization to the first observation of PD, death due to any cause, or early discontinuation of treatment. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of longest diameter of target lesions. TTF was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.
Measured: Baseline to stopping treatment up to 14.1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308750
- Sponsor's protocol ID
- 10651
- Other IDs
- H6Q-US-S004
- Status last verified
- Apr 2021
- First submitted
- 28 Mar 2006
- Last updated
- 13 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Socinski MA, Raju RN, Stinchcombe T, Kocs DM, Couch LS, Barrera D, Rousey SR, Choksi JK, Jotte R, Patt DA, Periman PO, Schlossberg HR, Weissman CH, Wang Y, Asmar L, Pritchard S, Bromund J, Peng G, Treat J, Obasaju CK. Randomized, phase II trial of pemetrexed and carboplatin with or without enzastaurin versus docetaxel and carboplatin as first-line treatment of patients with stage IIIB/IV non-small cell lung cancer. J Thorac Oncol. 2010 Dec;5(12):1963-9. doi: 10.1097/JTO.0b013e3181fd42eb.
PubMed 21102260
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Phase II Study of Pemetrexed (Alimta) Plus Carboplatin With or Without Enzastaurin Hydrochloride, or Docetaxel Plus Carboplatin as First Line Treatment in Patients With Advanced Stage Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00308750
- Acronym / sponsor ID
- 10651
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 30 Mar 2006 (estimated)
- Results
- Posted 13 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to determine:
The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or docetaxel with carboplatin and any side effects that might be associated with the combination of these drugs.
Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can help participants with non-small cell lung cancer (NSCLC) live longer, compared with the combination of docetaxel and carboplatin.
Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can make your tumor smaller or disappear, and for how long, compared with the combination of docetaxel and carboplatin.
The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or docetaxel with carboplatin have on your disease related symptoms.
The relation of smoking history and hormone replacement therapy (for women only) may have to your lung cancer treatment results.
The effects of certain genes and proteins in samples of your blood and tumor tissue in order to learn more about NSCLC and how enzastaurin works in the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enzastaurin/Pemetrexed/Carboplatin | Experimental | Drug: enzastaurin, Drug: pemetrexed, Drug: carboplatin |
| Pemetrexed/Carboplatin | Experimental | Drug: pemetrexed, Drug: carboplatin |
| Docetaxel/Carboplatin | Active comparator | Drug: docetaxel, Drug: carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- You must have been diagnosed with NSCLC.
- You must be able to visit the doctor's office weekly during the active treatment period and as needed during the study follow-up period.
- You must be willing and able to swallow capsules.
- Your entry labs and medical tests must meet study requirements.
- You must be willing to have blood samples drawn and tissue samples obtained for gene and protein testing.
Key exclusion criteria (5 listed)
- You have received radiation within 2 weeks of study enrollment.
- You have previously received any anti-cancer drug therapy for NSCLC.
- You have an active infection or other serious condition.
- You take aspirin or aspirin-like medication regularly and are not able to stop taking them for a few days during each cycle of chemotherapy.
- You have recently lost a significant amount of weight.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enzastaurinAlso: LY3176151125-1200 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression | Drug | Enzastaurin/Pemetrexed/Carboplatin |
| pemetrexedAlso: LY231514, Alimta500 milligrams per square meter (mg/m^2), intravenous (IV), once every (q) 21 days, six 21 day cycles or progressive disease | Drug | Enzastaurin/Pemetrexed/Carboplatin, Pemetrexed/Carboplatin |
| docetaxel75 mg/m^2, IV, q 21 days, six 21 day cycles or progressive disease | Drug | Docetaxel/Carboplatin |
| carboplatinArea under the curve (AUC) 6, IV, q 21 days, six 21 day cycles or progressive disease | Drug | Docetaxel/Carboplatin, Enzastaurin/Pemetrexed/Carboplatin, Pemetrexed/Carboplatin |
Primary outcome
Time to Disease Progression
Time frame: Baseline to measured PD up to 22.3 months
Time to disease progression was defined as the time from randomization to the first date of documented disease progression or death if the participant dies due to disease progression. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions. For participants who have not had documented disease progression, time to disease progression was censored at the date of death or date of last visit. For participants who received other anti-tumor therapy prior to disease progression, time to disease progression was censored at the first available date of other anti-tumor therapy.
9 secondary outcomes
Tumor Biomarkers Associated With Clinical Outcomes
Time frame: Baseline, Cycle 1, Cycle 2 (21-day cycle each), and 30-day post study treatment follow-up
Assessment of Smoking History (All Participants) and Hormone Replacement Therapy (Female Participants Only) Associated With Clinical Outcomes
Time frame: Baseline
Number of Participants With Adverse Events (AEs) or Deaths
Time frame: Baseline through study completion up to 6 cycles (21-day cycle each) and 30-day safety follow-up
Change From Baseline in Total Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale
Time frame: Baseline, Cycle 1 (Week 3), Cycle 2 (Week 6), Cycle 3 (Week 9), Cycle 4 (Week 12), Cycle 5 (Week 15) and Cycle 6 (Week 18) [21-day cycle each]
Change From Baseline in Total Functional Assessment of Cancer Therapy -Taxane (FACT-Taxane) Scale
Time frame: Baseline, Cycle 1 (Week 3), Cycle 2 (Week 6), Cycle 3 (Week 9), Cycle 4 (Week 12), Cycle 5 (Week 15) and Cycle 6 (Week 18) [21-day cycle each]
Overall Survival (OS)
Time frame: Baseline to date of death from any cause up to 35 months
Number of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response]
Time frame: Baseline to measured PD up to 22.3 months
Duration of CR or PR (Duration of Response)
Time frame: Date of first response to the date of progression or death due to any cause up to 22.3 months
Time-to-Treatment Failure (TTF)
Time frame: Baseline to stopping treatment up to 14.1 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21102260Socinski MA, Raju RN, Stinchcombe T, Kocs DM, Couch LS, Barrera D, Rousey SR, Choksi JK, Jotte R, Patt DA, Periman PO, Schlossberg HR, Weissman CH, Wang Y, Asmar L, Pritchard S, Bromund J, Peng G, Treat J, Obasaju CK. Randomized, phase II trial of pemetrexed and carboplatin with or without enzastaurin versus docetaxel and carboplatin as first-line treatment of patients with stage IIIB/IV non-small cell lung cancer. J Thorac Oncol. 2010 Dec;5(12):1963-9. doi: 10.1097/JTO.0b013e3181fd42eb.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing enzastaurin, pemetrexed and docetaxel in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Disease Progression (time frame: Baseline to measured PD up to 22.3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.